HIGH COURT RULING ON HUMAN GENES GREETED POSITIVELY

WASHINGTON 
The Supreme Court ruled Thursday that naturally occurring human genes may not be patented, potentially opening up commercial and scientific terrain to more freewheeling exploration.

In a unanimous decision that was greeted positively in San Diego’s large biotechnology industry, the court distinguished between genes found in the human body and those created in the lab. Stem cell and genomics scientists and business leaders said it clears hurdles to research and eliminates uncertainty.

“A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated,” Justice Clarence Thomas wrote for the court.

At the same time, Thomas and his fellow justices determined that so-called “complementary DNA,” or cDNA, which is synthetic, is “patent eligible because it is not naturally occurring.”

J. Craig Venter, the famed San Diego geneticist, praised the ruling while speaking at CalBio, the state’s biotech industry convention at the San Diego Convention Center.

“It reaffirms what all of us thought, that naturally occurring DNA, natural human genome sequences, natural genes, are not subjects for patentable material,” Venter said.

Most California biotech companies said the ruling will be beneficial, said Joe Panetta, CEO of Biocom, the San Diego-based life science trade group.

Panetta, Venter and others at CalBio cited the ruling’s allowance of patenting of cDNA. Some in the industry had worried that the court could overturn patents for genetically engineered drugs or agriculture products, on the theory they were derived from or copied from natural genes.

The manufacture and use of cDNA is common in biotech. In San Diego, Life Technologies sells kits to make cDNA, and gene products maker Zyagen sells asparagus cDNA on its website.

The decision in the closely watched case rejects several patent claims filed by a Utah company called Myriad Genetics. Myriad obtained patents, and with them a profitable monopoly, on the exact location of two genes associated with a higher risk of developing breast or ovarian cancer. Individual scientists who felt constrained by Myriad’s patents sued, along with a group called the Association for Molecular Pathology.

“We are thrilled,” said American Civil Liberties Union attorney Sandra S. Park, who argued the case. “The question before the court was a simple one, but it had profound consequences.”

The ruling means that competing firms now have a freer hand in developing cancer-testing tools that involve the genes for which Myriad held the patents. More broadly, Park said the ruling could call into question the validity of patents that have been issued for about 4,000 other human genes.

“As a result of this, the cost of genetic testing should come down significantly,” said Dr. Harry Ostrer, a medical geneticist at the Albert Einstein College of Medicine who challenged Myriad’s patents. “I think we will see a much more level playing field. It will drive down costs and improve quality.”

Park added that the court’s reasoning perhaps could be applied to challenges of patents that have been issued for nonhuman isolated genes.

Myriad officials accentuated the positive in the court’s decision, stressing how the court agreed that lab-synthesized cDNA still may be patented, as may the scientific methods used in isolating genes.